Immune Response to Vaccination Against Covid-19, a Follow up Study
NCT ID: NCT04920357
Last Updated: 2021-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
3000 participants
OBSERVATIONAL
2021-03-31
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim is to investigate the level of specific antibodies to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) yearly, up to 4 years after vaccination.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Host-pathogen Interactions, Immune Response, and Clinical Prognosis at COVID-19 - the CoVUm Trial
NCT04368013
Local and General Immune Response After Coronavirus Disease (COVID-19) Vaccination in Volunteers
NCT04996238
Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare With Regard to Vaccinations
NCT04853004
COVID-19 Vaccination of Immunodeficient Persons (COVAXID)
NCT04780659
The Influence of Trained Immunity in COVID-19 Vaccinated Individuals
NCT05705180
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The secondary objective is to improve the understanding of the cellular and serological immune response after vaccination against COVID-19 in these groups.
Individuals with and without pre-existing immunity to COVID-19 are included in the study. They are included after informed consent at sites where they receive vaccines against COVID-19 within the national and regional vaccine campaign.
The study includes all approved COVID-19 vaccines with marketing authorization in Sweden.
Persons are enrolled after the first or second dose of vaccination and followed 4 years after vaccination. Blood is collected at inclusion and 3 months, 6 months, 1 year, 2 years, 3 years and 4 years after vaccination to assess the immune response.
Data on sex, age, body mass index, medical history and concomitant medication is collected.
The study is a follow-up study after vaccination and approved by the Swedish Medical Products Agency (EudraCT 2021-000683-30). Regular monitoring of the study is performed by the Clinical Trial unit at Umeå University Hospital.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Post-COVID-19
Persons with a verified previous COVID-19 infection
Vaccination
Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.
COVID-19 naive
Persons that have no history of COVID-19
Vaccination
Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vaccination
Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years
Exclusion Criteria
* Incapable of giving informed consent
* Contraindication to vaccination
* Severe disease
* Ongoing treatment that is judged to affect the vaccine response (Does not include Rituximab which is allowed after individual consideration). Steroids \> 15 mg orally per day.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Region Västerbotten
OTHER_GOV
Värmland County Council, Sweden
OTHER_GOV
Örebro Läns Landsting
OTHER_GOV
Sormland County Council, Sweden
OTHER
Region Jämtland Härjedalen
OTHER
Umeå University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clas Ahlm, Prof
Role: PRINCIPAL_INVESTIGATOR
Umeå University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mälarsjukhuset
Eskilstuna, , Sweden
Karlstad Central hospital
Karlstad, , Sweden
Örebro University hospital
Örebro, , Sweden
Östersund hospital
Östersund, , Sweden
Umeå University hospital
Umeå, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Eudra-CT2021-000683-30
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.